Recall Z-0491-2022 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R FILTER (Model BB10Q85R); 2. CUSTOM PACK BB11C01R MIDI DEEP (Model BB11C01R); 3. CUSTOM PACK BB7H95R22 HYP MAIN (Model B7H95R22); 4. CUSTOM PACK BB7H95R25 HYP MAIN (Model BB7H95R25); 5. CUSTOM PACK BB7H99R22 NEONAT (Model BB7H99R22); 6. CUSTOM PACK BB7P4
| Date | Oct 12, 2021 |
| Status | Open, Classified |
| Reason | Product is labeled as non-pyrogenic but endotoxin testing was not performed. |
| Root cause | Under Investigation by firm |
| Action | Medtronic began notifying customers on 10/18/2021, via 2-day UPS delivery, with letter titled "URGENT MEDICAL DEVICE RECALL." Customers were instructed to review inventory for affected Medtronic Perfusion Tubing Packs, identify and quarantine any affected product found in inventory, return any affected product on hand by contacting Customer Service at 1-800-854-3570, Option1 then Option 4, and referencing this communication to initiate a return and credit of unused product. Additionally, customers were instructed to complete the enclosed Customer Confirmation Certificate and scan and email t |
| Quantity | 6,653 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, CT, IL, IN, KY, MA, ME, MS, NY, OH, RI, TN, TX, and VA. The countries of Canada, Columbia, France, Germany, Italy, Netherlands, Saudi Arabia, Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.